Brand Name
Klisyri
Generic Name
Tirbanibulin
View Brand Information FDA approval date: December 14, 2020
Classification: Microtubule Inhibitor
Form: Ointment
What is Klisyri (Tirbanibulin)?
KLISYRI is indicated for the topical treatment of actinic keratosis on the face or scalp. KLISYRI is a microtubule inhibitor indicated for the topical treatment of actinic keratosis of the face or scalp.
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Brand Information
Klisyri (tirbanibulin)
1INDICATIONS AND USAGE
KLISYRI is indicated for the topical field treatment of actinic keratosis on the face or scalp.
2DOSAGE AND ADMINISTRATION
For topical use only; not for oral or ophthalmic use.
Apply KLISYRI evenly to cover up to 100 cm
Wash hands immediately with soap and water after application.
Avoid washing and touching the treated area for approximately 8 hours after application of KLISYRI. Following this time, the area may be washed with a mild soap.
Avoid transfer of KLISYRI to the periocular area
Avoid application near and around the mouth and lips.
3DOSAGE FORMS AND STRENGTHS
Ointment: 1% white to off-white ointment supplied in a unit-dose packet (2.5 mg tirbanibulin in 250 mg or 3.5 mg tirbanibulin in 350 mg).
4CONTRAINDICATIONS
None.
5DESCRIPTION
KLISYRI (tirbanibulin) ointment is a microtubule inhibitor for topical use. The chemical name of tirbanibulin is
Tirbanibulin ointment 1% contains 10 mg tirbanibulin per gram of white to off-white ointment containing mono- and di-glycerides and propylene glycol.
6CLINICAL STUDIES
Actinic Keratosis of the Face or Scalp
Two double-blind, vehicle-controlled clinical trials (NCT03285477 and NCT03285490) were conducted with 702 adult subjects with actinic keratosis on the face or scalp. Subjects were randomized 1:1 to KLISYRI or vehicle. Subjects enrolled had 4 to 8 clinically typical, visible, and discrete AK lesions in a contiguous area of 25 cm
Subjects received 5 consecutive days of once daily treatment with either KLISYRI (353) or vehicle control (349) to the treatment field. Subjects with complete (100%) clearance of AK lesions in the treatment area at Day 57 returned to the clinic for recurrence assessment every 3 months for a total of 12 months post-Day 57.
The primary efficacy endpoint was complete (100%) clearance of AK lesions in the treatment area, defined as the proportion of subjects at Day 57 with no clinically visible AK lesions in the treatment area and the secondary endpoint was partial (≥75%) clearance of AK lesions in the treatment area. Results from both trials are presented below.
Efficacy was consistent across sex and age (<65 and ≥65 years) subgroups.
Subjects who achieved 100% clearance of AK lesions in the treatment area at Day 57 continued to be followed for up to 12 months following Day 57 to determine the recurrence rate. Recurrence was defined as the proportion of subjects with any identified AK lesion (new or previous lesion) in the previously treated area who achieved 100% clearance at Day 57. Of the 174 subjects treated with KLISYRI who were followed, the recurrence rate at 12 months post-Day 57 was 73%.
7HOW SUPPLIED/STORAGE AND HANDLING
KLISYRI is a white to off-white ointment and is supplied in unit-dose packets containing either 250 mg or 350 mg of tirbanibulin ointment 1%. Discard each unit-dose packet after use.
NDC 16110-391-05 (5 unit-dose packets each containing 250 mg of ointment)
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Ophthalmic Adverse Reactions
Advise patients that KLISYRI is not for ophthalmic use. Advise patients to avoid application around the eyes, and transfer of the drug into the eyes and to the periocular area. If accidental exposure occurs, advise patients to flush eyes with water and seek medical care
Local Skin Reactions
Inform patients that treatment with KLISYRI may lead to local skin reactions
Important Administration Instructions
Advise patients that KLISYRI is for topical use only. Advise patients to avoid application near and around the eyes, mouth and lips.
Instruct patients to:
- Wash hands well after applying KLISYRI to avoid transfer of the drug into the eyes and to the periocular area after application.
- Avoid washing and touching the treated area for 8 hours after treatment. Following this time, patients may wash the area with a mild soap and water
- Avoid inadvertent transfer of KLISYRI to other areas, or to another person.
Manufactured for: Almirall, LLC
9PRINCIPAL DISPLAY PANEL - NDC: 16110-391-05 - Carton Label
10PRINCIPAL DISPLAY PANEL - NDC: 16110-391-55 - Carton Label
